CN108883215A

CN108883215A - Guide assembly and its application method

Info

Publication number: CN108883215A
Application number: CN201780009271.5A
Authority: CN
Inventors: 瓦鲁万·吉瓦南丹; 罗伯特·史密斯
Original assignee: Knoop Lars Cv Co
Current assignee: Knoop Lars Cv Co
Priority date: 2016-02-03
Filing date: 2017-02-02
Publication date: 2018-11-23
Also published as: JP2019505316A; US10518009B2; US11135420B2; AU2017213810A1; CA3012066A1; US20200086021A1; US20170216506A1; EP3411092A1; EP3411092B1; WO2017136537A1; JP7021780B2; EP3411092A4

Abstract

The present invention provides a kind of for blood pump to be delivered to the assembly of the guide in the vascular system of subject (introducer assembly) and a kind of method using the assembly.

Description

Guide assembly and its application method

Cross-reference to related applications

This application claims 35 USC § 119 of 2 months 2016 U.S. Patent Application Serial Numbers 62/290,866 submitted for 3rd (e) priority, entire contents are incorporated herein by reference in their entirety.

Background technique

Technical field

The present invention relates generally to heart-assist device (CAD), more particularly, to a kind of delivering (delivery) tool, And it is assembled by using the means of delivery with the blood pump in subject's (subject) et al. Ke and positioning CAD (assembly) method.

Background information

The use of CAD is the well-known method for treating heart failure.Blood pump (that is, air bag) is placed in aorta It is interior, usually in the descending aorta of proximal end.Pump generally includes the discharge capacity (displacement volume) of 40-50cc, and and heart Tandem working is to increase blood flow.During diastole, pump is inflated, thus by the blood in aorta ascendens and the arch of aorta It drives in coronary artery and supplies oxygen with Cardiomyocytes.During heart contraction, when left ventricular contraction, pump is deflated to reduce Afterload.

Although the blood pump part of CAD use and implantation is well-known, traditional method for implantation may cause The risk of infection and other complication.It needs a kind of blood pump means of delivery and blood pump is delivered in the vascular system of subject Method, convenience is provided and reduces the risk of complication.

Summary of the invention

The present invention provides a kind of guides for blood pump to be delivered in the vascular system of subject (introducer) assembly and a kind of method using the assembly.

Correspondingly, in one aspect, the guide that the present invention provides a kind of for guiding blood pump assembles.The assembly packet It includes：A) axis of axis elongation along longitudinal direction, which has distal end, proximal end, along longitudinal axis from the inner cavity for distally extending to proximal end, And collet (collet) mechanism of proximal end is set for receiving seal wire；B) there is locking member proximally and distally, locking Component is adapted so that the distal end of locking member is reversibly couple to the proximal end of axis.There is locking member lock arrangement and unlock to match It sets, so that generating chucking power between chuck mechanism and seal wire when being in lock arrangement.

On the other hand, the present invention provides a kind of assembled using guide of the invention, and blood pump is directed to subject's Method in blood vessel.This method includes providing for guiding the guide of blood pump to assemble, when locking member is in unlocking configuration Seal wire is distally advanced by chuck mechanism by the inner cavity along guide axis and is pushed away towards the distal end of air bag (balloon) Come in extend inflatable bladders, locking member is transformed into lock arrangement, so that seal wire is slideably fixed in collet, makes gas Capsule is advanced in vascular system and promotes along the length of vascular system (such as blood vessel), and locking member is transformed into unlock and is matched It sets, recalls seal wire, and the distal end of axis and the driving line of blood pump are disconnected.In embodiment, lock is switched in locking member After fixed configuration, vacuum power can be applied to inflatable bladders.In one embodiment, air bag is pushed through CAD system Artery interface arrangement (AID) arrival end, the arrival end offer leads to vasotropic entrance.In a related embodiment, by gas Before capsule promotes blood vessel, sheath is applied in guide assembly and arrival end.

Detailed description of the invention

It is described in detail below and the present invention will be better understood in conjunction with attached drawing by reading, identical attached drawing in the accompanying drawings Label is used to indicate identical element, and wherein：

Fig. 1 schematically shows CAD, referred to herein as intravascular ventricle auxiliary system (iVAS), including blood pump 180, internal drive line 170, artery interface arrangement (AID) 150, skin interface device (SID) 400, external drive line 310, outer Portion's driver 320 and it is superimposed upon subcutaneous ECG lead 850 on torso model；

Fig. 2 schematically shows the guide assembly 50 for the blood pump in patient's body implantation CAD；

Fig. 3 is the cross-sectional view of the guide assembly of Fig. 2；

Fig. 4 is the locking member 90 of the guide assembly of Fig. 2 and Fig. 3 and the enlarged section of associated chuck mechanism 75 Figure；

Fig. 5 schematically shows the guide that blood pump 180 is couple to during being implanted into the patient blood pump 180 Assembly 50；

Fig. 6 A schematically shows the part that the CAD of patient's body is implanted by using AID 150；

Fig. 6 B is the viewgraph of cross-section of the AID 150 of Fig. 6 A；

Fig. 7 A shows the SID 400 including can plant base portion 500 and SID cap 600；

Fig. 7 B shows part 420 and subcutaneous part 430 on the skin of the SID 400 of Fig. 7 A when being arranged in patient's body；

Fig. 8 shows the arrival end for the occluded blood vessel graft (vascular graft) 110 during blood pump is implanted into Assembly 800；

Fig. 9 shows the guide assembly 50 during blood pump is implanted with optional suture 820 and assembles with arrival end 800 and the combined assembly of optional sheath 810, wherein optional suture 820 is arranged on the opposed open of sheath 810；

Figure 10 is the enlarged cross-sectional view of the distal portions of blood pump 180, and wherein blunt nosed the 85 of seal wire 80 are pushed away during delivering Enter the distal tip of blood pump；

Figure 11 shows the dress that guide assembly 50 is combined with vacuum plant 900 (i.e. syringe) during the implantation of blood pump Match.

Figure 12 schematically shows the blood pump 180 in the descending aorta of proximal end, and wherein the inflating catheter of the pump passes through AID 150 enters the vascular system of right subclavian artery；And

Figure 13 is schematically shown including blood pump 180, internal drive line 170, AID 150, SID 400, external drive The CAD of line 310 and peripheral driver 320.

Specific embodiment

U.S. Patent Application Serial Number 14/659,375 and 14/476,656 and U.S. Patent number 8,323,174 and 7, 892,162 are hereby incorporated by reference in its entirety.As U.S. Patent Application Serial Number 14/659,375 and 14/476,656 and the U.S. are special Component associated with CAD and its component, device, module, source code disclosed in benefit number 8,323,174 and 7,892,162 etc., As disclosed herein, it is also disposed in CAD and its component.In addition, U.S. Patent Application Serial Number 14/659,375 With 14/476,656 and U.S. Patent number 8,323,174 and 7,892,162 disclosed in function and method, it makes use of those Component, device, module, source code etc., it is possible to use CAD as described herein is operated.

The present invention is described with reference to the drawings in preferred embodiment in the following description, wherein identical digital representation is identical Or similar element.Throughout the specification the reference of " one embodiment ", " embodiment " or similar language is meaned to combine The a particular feature, structure, or characteristic of embodiment description is included at least one embodiment of the invention.Therefore, entire The phrase " in one embodiment ", " in embodiment " and the similar language occurred in specification can with but be not required to all refer to For identical embodiment.

Described feature of the invention, structure can be combined in any suitable manner in one or more embodiments Or characteristic.In the following description, many details are described to provide the thorough understanding to the embodiment of the present invention.However, phase Pass field it will be recognized that the present invention can be implemented in the case where none or multiple details, or use Other methods, component, material etc. implement the present invention.In other cases, be not shown or described in detail well known structure, material or Operation is to avoid fuzzy each aspect of the present invention.

Although guide assembly of the invention is usually disclosed with the use of the CAD of the disclosure together, it can with it is each Kind device is used together, and can be utilized in the various operations for being related to the Vascular implantation of blood pump device.

In a main embodiment, the CAD (referred to herein as iVAS) of the disclosure is based on being similar in aorta Counterpulsation (counterpulsation) principle of ballon pump (IABP) operates.The component of the system is as shown in Figure 1.It relaxes in heart During, the inflation of blood pump 180 pushes it against downstream by the blood in discharge (displace) aorta to increase the natural heart Dirty cardiac output.When heart contraction starts (peak value of R wave), blood pump 180 is deflated, it is subsequent penetrate blood during reduce actively Pulse pressure and acting needed for reducing left ventricle.For decades, counterpulsation has become the standard treatments of cardiogenic shock, it is possible to provide The circulatory support of a few hours to several weeks.

In various embodiments, the implantation of iVAS needs to be implanted into four components：AID 150, blood pump 180, SID 400 and interior Portion drives line 170.For the ease of implantation, Customization Tool and method are developed, is assembled including guide of the invention.

Therefore, in one aspect, the guide assembly that the present invention provides a kind of for introducing blood pump.With reference to Fig. 2-4, dress Include with 50：A) axis 55 of axis elongation along longitudinal direction, the axis have that distal end 60, proximal end 65, axis is from distal end 60 to close along longitudinal direction The inner cavity 70 that end 65 extends, and the chuck mechanism 75 for being used to receive seal wire 80 at proximal end 65 is set；And b) have remote The locking member 90 at end and proximal end, locking member are adapted so that the distal end of locking member is reversibly couple to the proximal end of axis.Locking Component has lock arrangement and unlocking configuration, so that when being in lock arrangement, in chuck mechanism 75 and insertion inner cavity 70 Chucking power is generated between seal wire 80.

It is worth noting that, the proximal end 65 of axis is suitable for forming Fluid Sealing with locking member 90.This can be by including 0 shape Ring 95 is realized.Fluid Sealing prevents the blood loss during blood pump 180 introduces vascular system.0 shape ring 95 is also in guide and blood Pump 180 between formed it is gas-tight seal, allow blood pump deflate during being inserted into vascular system.

Fig. 6 A and 6B show the AID 150 of the iVAS of the disclosure.Referring to Fig. 6 A, it is attached to using by suture ring 130 The blood vessel graft 110 of artery 120 forms blood vessel interface 100, and wherein suture ring 130 is located at the incision site in artery. Shown in specific graft opened at its distal end 140.AID 150 is located in graft 110, fills the inside of graft 110.

It is the first task that surgeon executes in implant system that suture ring 130, which is sewn onto subclavian artery,.It connects Get off, graft 110 is sewn onto suture ring 130.

It include main body 155 with reference to Fig. 6 A and 6B, AID 150.In certain embodiments, main body 155 includes polyurethane.At certain In a little embodiments, main body 155 includes polysiloxanes.In embodiment shown in figure 1A and 1B, main body 155 be formed include Two inner cavities extended through.Inner cavity 160 is for making internal drive line 170 pass through AID 150.

Second inner chamber 165 accommodate pressure sensor 190 for measuring angiosthenia and sensor lead 192,194, 196 and 198, sensor 190 is interconnected to SID 400 (Fig. 7 A and 7B).Sensor lead 192,194,196 and 198 is used for Electric power is provided to sensor 190, provides grounding connection, to the offer clock signal of sensor 190, and from sensor 190 to SID 400 communication arterial pressure signal.

It is filled by internal drive line 170 inner cavity 160 for extending through the length of AID 150.Internal drive line 170 is again at it It is distally connected to pump 180.In certain embodiments, it is (logical in the range of 3 to 6 millimeters to be formed with internal diameter for inflating catheter Often about 5 millimeters), although other diameters are also possible.

Unshowned in Fig. 6 A is the proximal end for driving line 170.Because pump 180 needs to inflate and put in phase with cardiac cycle Gas so as to be used as ventricular assist device, so blood pump 180 must by driving line 170 and driver (for example, air compressor or Pump) it is in fluid communication.

In this driver as shown in Figure 1 outside the main body embodiment in portion, SID 400 (Fig. 7 A and 7B) allows system Design be made of the part in the inner and outer portion of implantation patient body.Driving line 170 is attached to SID 400, and SID 400 is attached To fluid driver.In certain embodiments, driver 320, driving line 170 and pump 180 form closing (closed) air system System, wherein the closed system includes the volume of air for clearly limiting and accurately controlling.This sky for clearly limiting and accurately controlling Air volume is conducive to leak detection.

In certain embodiments, using the bellows such as, but not limited to driven by one or more linear actuators (bellows) movement of volume of air and air is accurately controlled.In the description of the skin interface device of this paper, line is driven 170 are alternatively referred to as internal drive line.

With reference to Fig. 8 and 9, in the implantation of blood pump 180, once it is completed as previously described the kiss of suture ring 130 and graft 110 It closes (anastomosis), the arrival end comprising iris valve assembles 800 (Fig. 8) and is inserted into graft 110 at its proximal end, produces Raw hemostasis.Then sheath 810 (Fig. 9) is optionally attached to the proximal end of arrival end assembly 800 by surgeon.Inside sheath 810 It is blood pump 180 in a deflated state.As shown in figure 9, the other end of sheath 810 ties up on the axis of guide assembly 50.Sheath 810 are attached on the axis of arrival end assembly 800 and guide assembly 50 by suture 820.The effect of arrival end is can be with Blood loss when pump insertion is reduced to the maximum extent.Sheath is used to collect any blood escaped by arrival end.Then by blood pump The vascular system of 180 implantation patients, i.e. descending thoracic aorta.For implantable pump, surgeon is inserted into and is directed downwards onto The subclavian artery of patient passes through aortic bifurcation under clavicle, is then moved down into final position along aorta.Pump does not have Mechanical rigid is to allow to be implanted into the case where no guide 50.

In embodiment, sheath is not needed in implantation.In such embodiments, in the implantation of blood pump 180, once It is completed as previously described coincideing for suture ring 130 and graft 110, the arrival end comprising iris valve assembles 800 (Fig. 8) and transplanting The proximal end of object 110 is inserted into graft 110, generates hemostasis.Since graft 110 can reversibly be clamped to prevent from losing Blood, therefore do not need sheath.Then blood pump 180 is implanted into the vascular system of patient, i.e. descending thoracic aorta.For implantable pump, Surgeon is inserted into and is directed downwards onto the subclavian artery of patient, passes through aortic bifurcation under clavicle, then along actively Arteries and veins is moved down into final position.The pump does not have mechanical rigid to allow to be implanted into the case where no guide 50.

During installation blood pump 180, seal wire 80 is inserted into blood pump 180, so that in the distal end of the blunt distal end contact pump of silk Side tip 85 (Figure 10).Therefore, seal wire 80 is located at during insertion in the central lumen of blood pump 180, rather than in auxiliary lumen In or on the outer surface of air bag.Then, as shown in figure 5, the distal end of guide axis to be attached mechanically to the proximal end of pump.Collet Mechanism 75 and associated locking member 90 be used to lock seal wire 80 in place.Then using vacuum plant 900 (that is, as schemed Syringe in 11) it is vacuumized on blood pump (not shown), minimize its size.Once placing blood pump, vacuum, extraction are discharged Seal wire 80 simultaneously removes axis.

In embodiment, arrival end assembly 800 can be removed during the implantation of blood pump 180.In this way, the internal diameter of port can With sufficiently large, make it possible to and accommodate AID 150 and guide assembly 50.For example, once blood pump 180 is placed on intra-arterial, Arrival end can be assembled to 800 disassemblies and slided above guide assembly 50 and seal wire 80 far from patient.In embodiment In, the internal diameter of arrival end is greater than about 5,6,7,8,9,10,11,12,13,14 or 15 millimeters.In one embodiment, arrival end Internal diameter is equal to or greater than about 7 or 8mm.

For the ease of placing and detecting blood pump 180, seal wire 80 or part of it during installation, it may include radiopaque Material.For example, blunt end 85 can be made of radiopaque material or otherwise include radiopaque material.Alternatively, Blood pump 180 or part of it may include radiopaque material.In another embodiment, seal wire 80 or part of it and blood Pump 180 or part of it all include radiopaque material.

Figure 12 (schematically) shows the graft 110 being placed in position on right subclavian artery.The position is advantageous Because its allow readily operation enter and it is relatively short at a distance from descending aorta.Figure 12, which is also shown, passes through suture 210 are fixed to the graft of AID 150.Other suitable positions of interface include moving under arteria carotis communis, brachiocephalic artery, left clavicle Arteries and veins, descending aorta and abdominal aorta.Also the downstream branch of aorta, such as arteria iliaca externa and femoral artery can be used.

Referring now to Figure 13, in embodiment, CAD or iVAS include 180, internal drive line 170, AID 150, SID of pump 400, external drive line 310 and peripheral driver 320.

In embodiment, blood pump 180 is sized and shaped in patient sustainer hangs inside, and is optionally wrapped Include radiopaque material.In certain embodiments, the wall of pump includes barrier material, or can be completely moisture-proof, so that in pump Air it is as dry as possible.A kind of possible barrier material for pump includes polyurethane.It in certain embodiments, will be a kind of Or a variety of polyether polyols are modified as including surface silicon end group.

Locate at its proximal end, pump 180 is connected to the distal end of driving line 170.AID's 150 is sized and shaped to make Line 170 is driven to pass through arterial wall.

The proximal end of internal drive line 170 is connected to the distal end of external drive line 310 by SID 400.External drive line 310 Proximal end is connected to driver 320.

Pump 180, internal drive line 170, SID 400, external drive line 170 and driver 320 can be filled with pumped medium Electricity.In certain embodiments, pumped medium includes fluid.Preferred pumped medium is air.In certain embodiments, it pumps 180, internal drive line 170, SID 400, external drive line 310 and driver 320 limit closed fluid system.In certain implementations In example, pump 180, internal drive line 170, SID 400, external drive line 310 and driver 320 include open system, wherein being Air bolus in system can be exchanged with ambient enviroment.

As it will appreciated by a person of ordinary skill, depending on the anatomical structure of patient, pump 180 can have various sizes.? In some embodiments, when being inflated to higher than maximum collapse pressure upper 10 to 20mmHg, pump 180 usually has about 40 to 60 cubes lis The swelling volume of rice.

In certain embodiments, sensor is connected to one or more communication interfaces, with pneumatic driving moving-wire 170 1 Sample across AID 150 and graft 110 and is connected to SID 400. in certain embodiments, these one or more communications connect Mouth provides data to controller.

In certain embodiments, one or more sensors are sent out by wired or wireless way to the SID 400 of applicant Send data.The example of sensor includes but is not limited to the electrical lead for being used to measure electrocardiogram, the sensor for detecting body temperature, uses Sensor, the direct or indirect sensor for detecting Intraarterial pressure in detection blood analyte (such as vim and vigour), and/or measurement The sensor of humidity in pump 180.Indirect sensors include, for example, but not limited to, the microphone for monitoring heart sound.

In certain embodiments, controller 530 is arranged in SID 400.In certain embodiments, controller 530 and outer Portion's driver 320 integrates.

In certain embodiments, controller 530 monitors cardiac cycle using the signal from one or more sensors, To monitor anti-beat cycles.In certain embodiments, controller 530 uses the group of the signal from one or more sensors It closes to monitor cardiac cycle.

In certain embodiments, sensor is used for determining the air condition in system.In certain embodiments, measurement is empty Whether correctly atmospheric pressure is pumped in inflation or system with determining with the presence or absence of leakage.In certain embodiments, air pressure is come from The data of sensor are sent to controller 530.

In certain embodiments, the sensor and controller 530 for pumping the arterial pressure at 180 and/or AID 150 are logical Letter.In certain embodiments, these sensors are transmitted to controller by conducting wire or the arterial pressure that wirelessly will test 530。

It include SID pedestal 500 and SID cap 600 referring now to Fig. 7 A, SID 400.SID pedestal 500 and SID cap 600 are by coupling It connects, to form airtight conduit between internal drive line 170 and external drive line 310.In this way, drive line 170, SID 400 and driving line 310 can be a part of closed fluid system.In certain embodiments, close with other using washer Envelope system forms gas-tight seal.

Referring now to Fig. 7 A and 7B, when the skin interface device 400 of implantation includes SID base portion 500 comprising Huan Zheti Interior subcutaneous part 430 is combined with part 420 on skin.SID cap 600 is attached to part 420 on skin.Those skilled in the art It will be understood that SID 400 can be implanted into the various different locations of patient, such as abdomen or chest.

Electric energy is wirelessly provided from SID cap 600 to SID pedestal 500 referring now to Fig. 7 A, SID 400, and also in SID Electric signal, i.e. data wirelessly and are bidirectionally transmitted between cap 600 and SID pedestal 500.In order to optimize from SID cap 600 to SID The power transmission of pedestal 500, and at the same time optimization SID cap 600 and SID pedestal 500 between data transmission, applicant incited somebody to action Data transmission and power transmission " decoupling ".It is completed from SID cap 600 to the power transmission of SID pedestal 500 by induction.

While preferred embodiments of the present invention have been illustrated in detail, by now it should be apparent that, do not departing from this paper institute In the case where the scope of the present invention stated, it may occur to persons skilled in the art that modification and adjustment to those embodiments.This hair Bright partly to be illustrated by following example, still, the invention is solely defined by the appended claims.

Claims

1. a kind of guide for introducing blood pump assembles, including：

A) axis of axis elongation, the axis have distal end, proximal end, extend to along the longitudinal axis from the distal end along longitudinal direction The inner cavity of the proximal end, and the chuck mechanism for being used to receive seal wire of the proximal end is set；And

B) there is locking member proximally and distally, the locking member is adapted so that the distal end of the locking member is reversible Ground is couple to the proximal end of the axis,

Wherein the locking member has lock arrangement and unlocking configuration, and

Wherein when being in the lock arrangement, clamping force is generated between the chuck mechanism and the seal wire.

2. assembly according to claim 1, wherein the distal end of the axis and the driving line fluid of blood pump device couple.

3. assembly according to claim 2, wherein hose barb is arranged on the distal end of the axis.

4. assembly according to claim 2, wherein the distal end of the axis is connected to institute via the pipe of intermediate length State driving line.

5. assembly according to claim 4, wherein the axis and driving line are easily connected by the manually handle of doctor It connects, the auxiliary without tool.

6. assembly according to claim 1, wherein the locking member and the axis are threadably attached.

7. assembly according to claim 6, wherein the locking member includes internal screw thread, and the axis includes outer spiral shell Line.

8. assembly according to claim 6, wherein the locking member includes external screw thread, and the axis includes interior spiral shell Line.

9. assembly according to claim 1, wherein the proximal end of the axis is suitable for forming fluid with the locking member Sealing.

10. assembly according to claim 9, wherein the proximal end of the axis includes that 0 shape ring is close to provide the fluid Envelope.

11. assembly according to claim 1, wherein the proximal end of the locking member is suitable for and pneumatic driving moving-wire fluid Coupling.

12. assembly according to claim 11, wherein hose barb is arranged on the proximal end of the locking member.

13. assembly according to claim 2, wherein the blood pump device includes elongated inflatable bladders, the air bag With proximally and distally, wherein the proximal end of the air bag is coupled to the driving line.

14. assembly according to claim 13, wherein the air bag is dimensioned so as to the row when implantable intravascular expands The fluid of 50cc out.

15. assembly according to claim 13, wherein the blood pump device includes radiopaque marker.

16. assembly according to claim 15, wherein radiopaque marker is arranged on the driving line, It is adjacent with the proximal end of the air bag.

17. assembly according to claim 2, wherein the seal wire includes the round table at the distal tip of the seal wire Face, the circular surface are configured to contact the distal end of the air bag.

18. assembly according to claim 17, wherein the circular surface includes sphere.

19. assembly according to claim 17, wherein the seal wire or part of it are made of radiopaque material.

20. assembly according to claim 19, wherein the circular surface includes radiopaque material.

21. a kind of be introduced into the method in the blood vessel of subject for blood pump, the method includes：

A) it provides the guide for introducing the blood pump to assemble, the guide assembly includes：

I) axis of axis elongation, the axis have distal end, proximal end, extend to along the longitudinal axis from the distal end along longitudinal direction The inner cavity of the proximal end, and the chuck mechanism for being used to receive seal wire of the proximal end is set；

Ii) there is locking member proximally and distally, the locking member is adapted so that the distal end of the locking member can It is couple to the proximal end of the axis inversely,

Wherein when being in the lock arrangement, chucking power is generated between the chuck mechanism and the seal wire；And

Iii) blood pump device, the blood pump device include driving line, and the driving line and elongated inflatable bladders couple, described Air bag has proximally and distally, and the proximal end of the air bag is coupled to the driving line, wherein the distal end of the axis It is coupled with the driving line fluid of the blood pump device；

B) it when the locking member is in the unlocking configuration, is distally advanced by the inner cavity along the axis described Seal wire is by the chuck mechanism and the distal end towards the air bag, to extend the inflatable bladders；

C) locking member is transformed into the lock arrangement, so that the seal wire is slideably fixed in the collet；

D) so that the air bag is advanced to described intravascular and promoted along the length of the blood vessel, wherein the seal wire is in the gas The inner cavity side contacts of the distal tip of the distal tip and air bag of the intracapsular intracavitary and described seal wire；

E) locking member is converted into the unlocking configuration；

F) seal wire is recalled；And

G) distal end of the axis and the driving line of the blood pump are disconnected.

22. further including according to the method for claim 21, right after the locking member is transformed into the lock arrangement The inflatable bladders apply vacuum.

23. according to the method for claim 21, wherein the air bag promotes the entrance for passing through artery interface arrangement (AID) End, the arrival end provide the entrance for entering and stating blood vessel.

24. further including according to the method for claim 23, before the air bag is advanced in the blood vessel described Apply sheath on guide assembly and the arrival end.

25. further including according to the method for claim 24, that will be arranged in above the driving line of the blood pump device Plug is sewn onto the vascular graphic of the AID, and the vascular graphic is stitched into the blood vessel, thus by the position of the air bag It is fixed on described intravascular.

26. according to the method for claim 25, further including making the vacuum applied reversion to incite somebody to action before recalling the seal wire Air introduce the air bag so that the cell parts inflate.

27. further including according to the method for claim 21, that the driving line is fluidly coupled to skin interface device (SID)。

28. according to the method for claim 21, wherein the air bag is placed in descending aorta.

29. according to the method for claim 21, wherein through air bag described in fluoroscopic observation in the blood vessel Position.

30. according to the method for claim 21, wherein the locking member and the axle thread be attached.

31. according to the method for claim 30, wherein the locking member includes internal screw thread, and the axis includes outer spiral shell Line.

32. according to the method for claim 30, wherein the locking member includes external screw thread, and the axis includes interior spiral shell Line.

33. according to the method for claim 21, wherein the proximal end of the axis is suitable for forming stream with the locking member Body sealing.

34. according to the method for claim 33, wherein the proximal end of the axis includes 0 shape ring to provide the Fluid Sealing.

35. according to the method for claim 21, wherein hose barb is arranged on the proximal end of the locking member.

36. according to the method for claim 21, wherein the air bag is dimensioned so as to the discharge in expandable implant The fluid of 50cc.

37. according to the method for claim 21, wherein radiopaque marker is arranged on the driving line, neighbouring The proximal end of the air bag.

38. according to the method for claim 21, wherein the seal wire includes the circle at the distal end of the seal wire Surface, the circular surface are configured to contact the distal end of the air bag.

39. according to the method for claim 38, wherein the circular surface includes sphere.

40. according to the method for claim 21, wherein the seal wire or part of it are made of radiopaque material.

41. according to the method for claim 21, wherein the seal wire is coated with polytetrafluorethylecoatings coatings.

42. further including according to the method for claim 23, that will be arranged in above the driving line of the blood pump device Plug is sewn onto the vascular graphic of the AID, and the vascular graphic is stitched into the blood vessel, thus by the position of the air bag It is fixed on described intravascular.

43. according to the method for claim 42, further including making the vacuum applied reversion to incite somebody to action before recalling the seal wire Air introduces the air bag partly inflate the air bag.

44. further including according to the method for claim 43, recalling the arrival end before recalling the seal wire.

45. further including according to the method for claim 21, recalling the arrival end before recalling the seal wire.